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Inside ODAC’s Vote on Sotorasib in Advanced and Metastatic NSCLC: Lessons Learned
Manage episode 407461991 series 3560609
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Last month, a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) determined that progression-free survival (PFS) could not be reliably interpreted in a confirmatory clinical trial for sotorasib (Lumakras) used to treat KRAS G12C–mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Ravi A. Madan, MD, senior clinician at the National Cancer Institute’s Center for Cancer Research and chair of the ODAC, speaks with Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at Cedars-Sinai Cancer Center in Los Angeles, about broader implications from the 2-10 vote against the sotorasib data. They discuss the specific rationale behind the decision, as well as what this means for clinical practice in the short term and big picture solutions to help improve future trials.
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